510(k) Report

510(k) · Cleared

Cleared

Kodak Ektachem Dtii System

K912844510(k) TraditionalCleared Sep 4, 199170-day reviewClass I21 CFR 862.2160

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Eastman Kodak Company · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Cleared on Sep 4, 1991 after a 70-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 31 later devices descend from it.

Decided
Sep 4, 1991
Review
70 days
Class
Class I
Product code
JJE
Recalls
None
Predicates
0

31 later devices descend from it, 29 citing it directly.

Descendants, by year cleared 1998: 13 descendants cleared2002: 4 descendants cleared1999: 10 descendants cleared2009: 2 descendants cleared2008: 1 descendant cleared2010: 1 descendant cleared1990200020102020
  1. This deviceK912844 Kodak Ektachem Dtii SystemEastman Kodak Company · 1991
  2. Descendant · cites it directly · 3 of its ownK082099 Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2008
  3. Descendant · cites it directly · 2 of its ownK083680 Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2009 · Recalled
  4. Descendant · 2 generations on · 1 of its ownK091861 Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT…Ortho-Clinical Diagnostics, Inc. · 2009
  5. Descendant · cites it directly · 1 of its ownK980056 Careside AnalyzerExigent Diagnostics, Inc. · 1998
  6. Descendant · 3 generations on · 0 of its ownK093611 Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products…Ortho-Clinical Diagnostics, Inc. · 2010

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

1998: 131999: 102002: 42008: 12009: 22010: 1
1998high 13 (1998) · low 0 (2000)2026

Most influential descendants

Showing 5 of 31 · See all
  • K082099Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2008 · cites it directly3descendants
  • K083680Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2009 · cites it directly2descendants
  • K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…Ortho-Clinical Diagnostics, Inc. · 2009 · 2 generations on1descendant
  • K980056Careside AnalyzerExigent Diagnostics, Inc. · 1998 · cites it directly1descendant
  • K093611Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2010 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912844Kodak Ektachem Dtii SystemEastman Kodak Company1991—
+1K082099Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc.2008—
+1K083680Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator…Ortho-Clinical Diagnostics, Inc.20091
+2K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator…Ortho-Clinical Diagnostics, Inc.2009—
+1K980056Careside AnalyzerExigent Diagnostics, Inc.1998—
+3K093611Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT…Ortho-Clinical Diagnostics, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
1998130
1999100
200240
200810
200920
201010
FIG. 1 — Lineage of K912844, 1991–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JJE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (31)

See all 31

29 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082099Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc.20083
K083680Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc.20092
K980056Careside AnalyzerExigent Diagnostics, Inc.19981
K020484Careside LDHCareside, Inc.20020
K020486Careside GGTCareside, Inc.20020
K020487Careside AltCareside, Inc.20020
K020488Careside TrglycerideCareside, Inc.20020
K993634Careside AnalyzerCareside, Inc.19990
K992475Careside CO2, TotalCareside, Inc.19990
K991717Careside MGCareside, Inc.19990

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K082099 (Ortho-Clinical Diagnostics, Inc., 2008) has gone furthest, with 3 descendants of its own.

How does its category compare?

All JJE devices

JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJE

1in 2019

2008: 12011: 22012: 12013: 12014: 32019: 1
2007high 3 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJE

224in 2014

2014: 224 days median
2007high 224 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJE

6in 2025

2007: 202008: 202009: 142010: 322011: 252012: 162013: 212014: 142015: 152016: 92017: 182018: 172019: 72020: 72021: 62023: 122024: 62025: 62026 (partial year): 5
2007high 32 (2010) · low 0 (2022)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJE

4,400in 2025

2007: 2,1812008: 2,1592009: 3,4402010: 3,2732011: 11,6062012: 3,7072013: 2,4892014: 2,8412015: 2,7932016: 2,5802017: 1,8692018: 4,5902019: 3,9482020: 3,9862021: 3,9202022: 3,9982023: 3,7832024: 4,2212025: 4,400
2007high 11,606 (2011) · low 1,869 (2017)2025

MAUDE reports naming product code JJE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—202,181
20081—202,159
20090—143,440
20100—323,273
20112—2511,606
20121—163,707
20131—212,489
20143224142,841
20150—152,793
20160—92,580
20170—181,869
20180—174,590
20191—73,948
20200—73,986
20210—63,920
20220—03,998
20230—123,783
20240—64,221
20250—64,400
20260—5—

More from Eastman Kodak Company

238 FDA decisions under this applicant name. See the company

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  • K060055Kodak PacsEastman Kodak Company · 2006
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The JJE category page

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https://510kreport.com/device/K912844 · printed Nov 6, 2026

Cite this page

510(k) Report. “K912844: Kodak Ektachem Dtii System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912844

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026